Scientist, Quality Control - Night Shift

Scientist, Quality Control
- Night Shift

The Scientist, Quality Control
- Night Shift conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis of processes leading up to drug product according to established operating procedures. Compiles data for documentation of test procedures. Calibrates and maintains lab and analytical equipment. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities.

Revises and updates standard operating procedures as needed. May perform special projects.

Specific Responsibilities:

• Perform routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols
• Perform a broad variety of basic and moderate complex tests in support of lab operations, including but not limited to flow cytometry and other cell-based assays
• Record and document all quality control testing activities accurately and in compliance with cGMP regulations and company procedures
• Assist in the preparation and review of batch records, standard operating procedures (SOPs), and other relevant documentation
• Perform routine lab maintenance, including equipment qualification/maintenance
• Prepare basic and complex reagents as assigned
• Order and maintain lab supply inventory
• Aliquot samples as required, including aseptic aliquoting
• Participate in assay transfer and assay validation
• Identify and support resolution of technical problems
• Actively participate in group and project teamwork; project and process improvements
• Receive and provide training
• Perform other duties as requested by supervisor/manager to support Quality
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products

General Requirements:

• Communicate effectively with team members and contribute to a positive and collaborative work environment
• Actively participate in group and project teamwork; project and process improvements
• Strong organizational skills and the ability to manage multiple tasks concurrently
• Willingness to learn and adapt in a fast-paced, dynamic environment
• Adhere to cGMP policies and procedures, including documentation activities
• Able to wear appropriate personal protective equipment

Desired Experience:

• Bachelor's degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) required
• 2-4 years of experience in quality control testing, analytical development, or biologics GMP preferred; candidates with less experience may be considered for Associate Scientist role. Master's degree may substitute for years of experience
• Moderate understanding of analytical techniques, laboratory equipment, and quality control principles
• Some experience in aseptic technique, flow cytometry, or cell-based assays
• Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred
• Able to meet project and testing timelines
• Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management.
• Able to work collaboratively to respond to changing priorities and challenges
• Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment

Night Shift Hours Worked:

• 6:00pm to 6:30am or
• 6:30pm to 7:00am

Work Week Schedule:

• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday

Physical Demands

• Production Associate Roles:
  Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Work Conditions

• Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

$65,000 - $95,000 a year The night shift receives a +7% night shift differential.

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to…